Sujit Dike Presents Gyder Surgical at LSI USA ‘23

Transcription

Sujit Dike  0:05  

Thank you. My name is Sujit Dike. I'm the CEO of Gyder Surgical, we have developed a pinless and imageless hypnotic ation system for accurately placing a cup into the hip socket during hip surgery. This is a big deal as 80% of surgeons currently do not use any technology. In fact, they freehand and simply cut place a cut into the hip socket, often missing the targeted angles and leading to patient complications and costly revisions. As you will see later in the presentation, the Gyder has Simpson has addressed two of the biggest barriers to adoption of current technologies, namely the use of metallic pins that get inserted into the patient's pelvis and use of imaging like CT or X ray, both of which add time, cost and complexity to the procedure. The technology was invented in Australia, we are on the verge of commercialization, with first in human cases expected in the mid June timeframe of this year in Australia. Good our studies to date have shown reproducible accuracy, clinical revelant relevant accuracy across a wide range of target angles. And we are collecting additional data to be included in our 510 K application, which we expect to be cleared by the FDA early next year and then commercialization right after that strong IP position with validated and approved patents in most major countries. And the technology itself has indications or potential to be applied for additional indications beyond our first product which is for the anterior approach where the patient lies on the back and the surgeon comes from the front. Incorrect positioning can lead to a lot of issues, including what you see on the top image here dislocation, when the prosthesis can completely come off the hip socket and the bottom you see liner where and there are a lot of other issues that over over a period of time can lead to costly revisions. In fact, a significant percentage of hip revisions occur because of malposition caps 40% of them, costing $2 billion dollars in total impact to the health system. Most navigation systems and robotic solutions actually use metallic plans shown in the images here that are inserted into the patient's pelvis can lead to infection can lead to interoperate a fracture. And obviously at time no surgeon likes to deal with any of these complications and add time. Let me show you how the goddess guidance system works. Okay, the warning was off. But let me let me walk you through this interruption workflow.

Video playing  2:38  

Before starting the operation. The surgeon or assistant says the orthopedic brace to the patient's pelvis using the patient's asis edge pubic symphysis. The surgeon then inputs their desired inclination and anti version angles into the guided navigation unit, attaches the navigation unit to the brace and places the brace to the side until ready to use. The surgeon now prepares the patient to receive the implant using their normal workflow. When the surgeon is ready to implant the cuff, they position the orthopedic brace onto the patient's pelvis over the ASIS and pubic symphysis and apply gentle pressure until they feel the brace is located on the underlying pelvic structure. When comfortable that the brace is seated, the assistant presses the OK button on the navigation unit to capture the orientation of the patient's anterior pelvic playing. The surgeon now transitions the navigation unit from the brace to the impactor. Using the visual feedback on the navigation unit, the surgeon manipulates the impactor into their chosen orientation for the acid tabula cup and then impacts the cup into place.

Sujit Dike  4:00  

We are targeting a large market, the hip market itself is $1.4 billion. And with additional indications beyond hip, we can potentially unlock an additional three and a half billion dollars in market opportunity. And as you saw from the video, the product itself is very simple to use. It's portable, you can provide it provides real time guidance, surgical guidance during impaction. Compared to robotics, as you heard probably from the panel this morning. It you know robotics takes a lot of footprint requires a dedicated or specialist and obviously is very expensive to health systems. Most of the systems are also equally expensive at time and complex training is required. And they all use pens by the way. In fact, our system is so easy to use that if you focus on the bottom, bottom rows in this table here. We have been able to train surgeons literally in an hour and they are up and running compared to systems like robotics where you have to go through six months certification often an extensive number of cases with For the surgeon feels comfortable. And the impact on procedure time, this is super important. We are super fast, it barely takes a minute to two minutes, including calibration and registration. For the entire procedure, again, we are not adding any time compared to most of the systems. So that's a massive advantage. We're going in with a razor razor blade model, where we have the option to place all the equipment at no cost in the hospital. It's all reusable realizable. And then we plan to charge per procedure using a single use disposable kit with very attractive margins, unit economics of 80%. Again, all of this combined together physicians guide are very well to capitalize in the ASC or outpatient surgery space, which is the biggest trend in the hip space today. We got phenomenal feedback at the largest orthopedic conference two weeks ago. All the surgeons like the pinless, no hassle, no Prem experience, as well as how fast it was. In fact, 89% of surgeons that we surveyed are interested in trying guider and some of the reasons cited include the fact that it can work with any implant, as well as the seamless and easy integration into existing workflows. Again, a big difference compared to more complex systems that exist in the marketplace. We have a strong and very well seasoned board across across across this management team. I want to highlight Bill Hill who has decades of product development experience, and our board of directors are both located in US and Australia. Again, very rich in and very well seasoned board here. We have a strong partnership in place to commercialize the product. Hydrex has been a phenomenal partner during our entire development process. And they are also a strategic investor. They are in fact here in the conference, I would encourage you to meet them if you're interested. And then all our manufacturing partnerships are in already in place to commercialize the product, starting this quarter. And then on the clinical side, we have a very strong roster of surgeons both in the US and Australia. And we continue to build upon that as we move forward. continued interest in the space by most large strategic orthopedic players a lot of activity over the years in terms of acquisition and m&a, and partnerships. But none of these players today have pinless and imaged the system. And certainly most of them do not have the attractive unit economics that I talked about earlier, we have been extremely efficient with our capital raise and what we have achieved to date we have raised $4.7 million, four of which, 4 million is private equity, private placement and then $700,000 in Australian grants. With that we have completed development of our anterior approach product and on the verge of commercialization in two major markets, US and Australia and also made a lot of progress on the posterior application. We are currently closing a seed extension down, it has been quite a busy quarter. In fact, we are already oversubscribed. Compared to the original target that we were planning to expedite our commercial preparation for Australia, as well as go through the rest of the 510 K process. So if any of you are interested in participating in this round, before we close, I would be very happy to talk to you after this presentation. And then in the future, we plan to raise another $7 million later this year, to expand our indication and complete our posterior development and regulatory submissions as well as commercialized in the US and into Japan. So again, a very, very capital efficient approach in what we have achieved so far. And just to close it out. We have a highly differentiated, fast, cost effective and simple to use products that we believe can address the need of 80% of market that is not being served by existing technology. Thank you for your time